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510(k) K171440

Berkeley VC-10 Vacuum Curettage System by Gyrus Acmi — Product Code HHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2017
Date Received
May 16, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Abortion, Vacuum
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type

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Other clearances for product code HHI

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  • K983181 — CYTOPREP (November 16, 1998)
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  • K904160 — CYTOSMEAR BRUSH (November 2, 1990)
  • K900641 — CANNULA, SUCTION UTERINE (March 30, 1990)
  • K900642 — SWIVEL ADAPTER (March 19, 1990)
  • K880734 — SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (April 25, 1988)
  • K873552 — CANNULA AND GENERAL PURPOSE ASPIRATOR (November 25, 1987)
  • K870574 — COSMEDTECH GENERAL ASPIRATOR (March 5, 1987)
  • K870560 — COSMEDTECH CANNULA (March 4, 1987)